Research Spotlight

Abed, P. F., E. El Chaar, F. Boltchi and S. H. Bassir (2020). “The Novel Periosteal Flap Stretch Technique: A Predictable Method to Achieve and maintain Primary Closure in Augmentative Procedures.” J Int Acad Periodontol 22(1): 11-20.

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BACKGROUND: Correct soft tissue management and achieving tension-free primary closure are pre-requisites for the success of bone augmentation procedures. Several techniques have been developed to facilitate a passive soft tissue primary closure. However, the current techniques are highly invasive and require advanced surgical skills. Hence, the present case series report will describe a novel and simple flap management technique. METHODS: The Periosteal Flap Stretch technique was utilized in bone augmentation procedures for four patients who presented with horizontal and vertical alveolar ridge deficiencies in the anterior maxilla, anterior mandible, posterior mandible, and posterior maxilla. This technique is performed using a blunt surgical curette that engages the periosteum of the mucosa below the mucogingival line of the full-thickness flap and stretches the periosteum in a coronal and outward direction, which results in stretching of the flap without the need for vertical or periosteal releasing incisions. RESULTS: Healing was uneventful for four all cases. No membrane exposure, no soft tissue dehiscence, or any other complications were observed during the six-months healing period after the respective bone augmentation procedures of cases. CONCLUSIONS: The Periosteal Flap Stretch technique is a novel and simple technique that facilities achieving passive and predictable primary soft tissue closure.

Dangas, G. D., J. G. P. Tijssen, J. Wohrle, L. Sondergaard, M. Gilard, H. Mollmann, R. R. Makkar, H. C. Herrmann, G. Giustino, S. Baldus, O. De Backer, A. H. C. Guimaraes, L. Gullestad, A. Kini, D. von Lewinski, M. Mack, R. Moreno, U. Schafer, J. Seeger, D. Tchetche, K. Thomitzek, M. Valgimigli, P. Vranckx, R. C. Welsh, P. Wildgoose, A. A. Volkl, A. Zazula, R. G. M. van Amsterdam, R. Mehran and S. Windecker (2019). “A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement.” New England Journal of Medicine Nov 16. [Epub ahead of print].

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BACKGROUND: Whether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear. METHODS: We randomly assigned 1644 patients without an established indication for oral anticoagulation after successful TAVR to receive rivaroxaban at a dose of 10 mg daily (with aspirin at a dose of 75 to 100 mg daily for the first 3 months) (rivaroxaban group) or aspirin at a dose of 75 to 100 mg daily (with clopidogrel at a dose of 75 mg daily for the first 3 months) (antiplatelet group). The primary efficacy outcome was the composite of death or thromboembolic events. The primary safety outcome was major, disabling, or life-threatening bleeding. The trial was terminated prematurely by the data and safety monitoring board because of safety concerns. RESULTS: After a median of 17 months, death or a first thromboembolic event (intention-to-treat analysis) had occurred in 105 patients in the rivaroxaban group and in 78 patients in the antiplatelet group (incidence rates, 9.8 and 7.2 per 100 person-years, respectively; hazard ratio with rivaroxaban, 1.35; 95% confidence interval [CI], 1.01 to 1.81; P = 0.04). Major, disabling, or life-threatening bleeding (intention-to-treat analysis) had occurred in 46 and 31 patients, respectively (4.3 and 2.8 per 100 person-years; hazard ratio, 1.50; 95% CI, 0.95 to 2.37; P = 0.08). A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53). CONCLUSIONS: In patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy. (Funded by Bayer and Janssen Pharmaceuticals; GALILEO ClinicalTrials.gov number, NCT02556203.).

Al-Bawardy, R., S. Vemulapalli, V. H. Thourani, M. Mack, D. Dai, A. Stebbins, I. Palacios, I. Inglessis, R. Sakhuja, E. Ben-Assa, J. J. Passeri, J. P. Dal-Bianco, E. Yucel, S. Melnitchouk, G. J. Vlahakes, A. S. Jassar and S. Elmariah (2019). “Association of Pulmonary Hypertension With Clinical Outcomes of Transcatheter Mitral Valve Repair.” JAMA Cardiol Nov 20. [Epub ahead of print].

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Importance: Pulmonary hypertension (pHTN) is associated with increased risk of mortality after mitral valve surgery for mitral regurgitation. However, its association with clinical outcomes in patients undergoing transcatheter mitral valve repair (TMVr) with a commercially available system (MitraClip) is unknown. Objective: To assess the association of pHTN with readmissions for heart failure and 1-year all-cause mortality after TMVr. Design, Setting, and Participants: This retrospective cohort study analyzed 4071 patients who underwent TMVr with the MitraClip system from November 4, 2013, through March 31, 2017, across 232 US sites in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry. Patients were stratified into the following 4 groups based on invasive mean pulmonary arterial pressure (mPAP): 1103 with no pHTN (mPAP, <25 mm Hg [group 1]); 1399 with mild pHTN (mPAP, 25-34 mm Hg [group 2]); 1011 with moderate pHTN (mPAP, 35-44 mm Hg [group 3]); and 558 with severe pHTN (mPAP, >/=45 mm Hg [group 4]). Data were analyzed from November 4, 2013, through March 31, 2017. Interventions: Patients were stratified into groups before TMVr, and clinical outcomes were assessed at 1 year after intervention. Main Outcomes and Measures: Primary end point was a composite of 1-year mortality and readmissions for heart failure. Secondary end points were 30-day and 1-year mortality and readmissions for heart failure. Linkage to Centers for Medicare & Medicaid Services administrative claims was performed to assess 1-year outcomes in 2381 patients. Results: Among the 4071 patients included in the analysis, the median age was 81 years (interquartile range, 73-86 years); 1885 (46.3%) were women and 2186 (53.7%) were men. The composite rate of 1-year mortality and readmissions for heart failure was 33.6% (95% CI, 31.6%-35.7%), which was higher in those with pHTN (27.8% [95% CI, 24.2%-31.5%] in group 1, 32.4% [95% CI, 29.0%-35.8%] in group 2, 36.0% [95% CI, 31.8%-40.2%] in group 3, and 45.2% [95% CI, 39.1%-51.0%] in group 4; P < .001). Similarly, 1-year mortality (16.3% [95% CI, 13.4%-19.5%] in group 1, 19.8% [95% CI, 17.0%-22.8%] in group 2, 22.4% [95% CI, 18.8%-26.1%] in group 3, and 27.8% [95% CI, 22.6%-33.3%] in group 4; P < .001) increased across pHTN groups. The association of pHTN with mortality persisted despite multivariable adjustment (hazard ratio per 5-mm Hg mPAP increase, 1.05; 95% CI, 1.01-1.09; P = .02). Conclusions and Relevance: These findings suggest that pHTN is associated with increased mortality and readmission for heart failure in patients undergoing TMVr using the MitraClip system for severe mitral regurgitation. Further efforts are needed to determine whether earlier intervention before pHTN develops will improve clinical outcomes.

Xenogiannis, I., D. Karmpaliotis, K. Alaswad, F. A. Jaffer, R. W. Yeh, M. Patel, E. Mahmud, J. W. Choi, M. N. Burke, A. H. Doing, P. Dattilo, C. Toma, B. Uretsky, O. Krestyaninov, D. Khelimskii, E. Holper . . . and E. S. Brilakis (2020). “Impact of concomitant treatment of non-chronic total occlusion lesions at the time of chronic total occlusion intervention.” Int J Cardiol 299: 75-80.

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BACKGROUND: During chronic total occlusion (CTO) percutaneous coronary intervention (PCI), sometimes non-CTO lesions are also treated. METHODS: We compared the clinical and procedural characteristics and outcomes of CTO PCIs with and without concomitant treatment of a non-CTO lesion in a contemporary multicenter CTO registry. RESULTS: Of the 3598 CTO PCIs performed at 21 centers between 2012 and 2018, 814 (23%) also included PCI of at least one non-CTO lesion. Patients in whom non-CTO lesions were treated were older (65+/-10 vs. 64+/-10years, p=0.03), more likely to present with an acute coronary syndrome (32% vs. 23%, p<0.01), and less likely to undergo PCI of a right coronary artery (RCA) CTO (46% vs. 58%, p<0.01). The most common non-CTO lesion location was the left anterior descending artery (31%), followed by the circumflex (29%) and the RCA (25%).Combined non-CTO and CTO-PCI procedures had similar technical (88% vs. 87%, p=0.33) and procedural (85% vs. 85%, p=0.74) success and major in-hospital complication rates (3.4% vs. 2.7%, p=0.23), but had longer procedure duration (131 [88, 201] vs. 117 [75, 179] minutes, p<0.01), higher patient air kerma radiation dose (3.0 [1.9, 4.8] vs. 2.8 [1.5, 4.6] Gray, p<0.01) and larger contrast volume (300 [220, 380] vs. 250 [180, 350] ml, p<0.01). CONCLUSIONS: Combined CTO PCI with PCI of non-CTO lesions is associated with similar success and major in-hospital complication rates compared with cases in which only CTOs were treated, but requires longer procedure duration and higher radiation dose and contrast volume.

Wong, K., K. Tecson and A. Cedars (2019). “Outcomes of Multi-Organ Transplant in Adult Patients With Congenital Heart Disease.” J Am Heart Assoc Nov 19;8(22):e014088. [Epub 2019 Nov 13].

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Background: The prevalence of adult congenital heart disease (ACHD) is increasing in the United States because of improved survival into adulthood. The unique physiology of ACHD commonly leads to multiorgan dysfunction, prompting interest in outcomes after multiorgan (heart+X) transplantation. Methods and Results: We queried the SRTR (Scientific Registry of Transplant Recipients) database to examine 5-year outcomes in ACHD patients (aged >/=18 years) who underwent dual organ (heart+kidney/liver/lung) transplantation between 2000 and 2016. Cox proportional hazards models were constructed to look at survival of dual organ transplant recipients versus heart-only recipients in the ACHD population and heart+lung recipients versus heart-only recipients in the ACHD populations and versus non-ACHD recipients of heart+lung transplant. We then constructed a multivariable model to investigate independent risk factors for 5-year mortality after multiorgan transplant. Overall, 5-year mortality was greater for multiorgan (heart+kidney/liver/lung) transplant compared with heart-only transplant. On further analysis, only heart+lung transplant was associated with increased mortality. Outcomes after heart+lung transplant were no different between the ACHD and non-ACHD population. Risk factors for increased risk of 5-year mortality in ACHD patients after multiorgan transplant included heart+lung transplant, previous cardiac surgery, and severe functional limitation. Conclusions: The mortality risk associated with multiorgan heart transplant in ACHD patients is attributable primarily to heart+lung transplants. Multiorgan transplant in ACHD does not convey increased risk compared with the non-ACHD population. Need for multiorgan transplant should not be an impediment to listing ACHD patients needing a heart transplant.